RECRUITING

ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

Official Title

ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

Quick Facts

Study Start:2021-10-25
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04933851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Spanish or English-speaking
  2. * Type 1 diabetes
  3. * Glycosylated Hemoglobin (HbA1c) 7.5% - 12.5% in last 90 days
  4. * Screen positive for diabetes distress
  1. * Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
  2. * Plans to move out of the San Diego area in the next 12 months
  3. * Lack of technology capability required to complete online surveys and telemedicine visit

Contacts and Locations

Study Contact

Haley Sandoval
CONTACT
970-497-6701
sandoval.haley@scrippshealth.org
Addie Fortmann, PhD
CONTACT
858-678-7059
fortmann.adelaide@scrippshealth.org

Principal Investigator

Addie Fortmann, PhD
PRINCIPAL_INVESTIGATOR
Scripps Whittier Diabetes Institute
Athena Philis-Tsimikas, MD
PRINCIPAL_INVESTIGATOR
Scripps Whittier Diabetes Institute

Study Locations (Sites)

Scripps Whittier Diabetes Institute
San Diego, California, 92121
United States

Collaborators and Investigators

Sponsor: Scripps Whittier Diabetes Institute

  • Addie Fortmann, PhD, PRINCIPAL_INVESTIGATOR, Scripps Whittier Diabetes Institute
  • Athena Philis-Tsimikas, MD, PRINCIPAL_INVESTIGATOR, Scripps Whittier Diabetes Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-25
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-10-25
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Type 1 Diabetes
  • Emotional Distress

Additional Relevant MeSH Terms

  • Type 1 Diabetes